Status:
ACTIVE_NOT_RECRUITING
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
Lead Sponsor:
Formycon AG
Conditions:
Melanoma, Stage II
Melanoma Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with...
Eligibility Criteria
Inclusion
- Patients with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma (as classified by the American Joint Committee on Cancer \[AJCC\]'s Cancer Staging Manual, 8th Edition) who have undergone complete resection within 12 weeks before randomization. No evidence of past or current satellites or in-transit metastases.
- Disease status for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) with neck CT and/or MRI (for head and neck primaries) and must have completed a clinical examination after the informed consent form has been signed and before enrollment.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Caucasian adult patients ≥18 years of age on the day of signing the informed consent.
Exclusion
- History of radiation therapy for melanoma before trial entry. Post-lymph node dissection radiotherapy is allowed; however, this should be completed at least 7 days before treatment starts.
- Uveal or ocular melanoma.
- Diagnosis of immunodeficiency or receiving long-term systemic steroid therapy (\>10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy ≤7 days before the first dose of IMP.
- Received prior therapy with an anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) monoclonal antibody (eg, ipilimumab), anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Received prior systemic anticancer therapy for melanoma.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06551064
Start Date
July 1 2024
End Date
June 30 2026
Last Update
September 4 2025
Active Locations (17)
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1
Formycon Investigative Site
Sarajevo, Bosnia and Herzegovina
2
Formycon Investigative Site
Sofia, Bulgaria
3
Formycon Investigative Site
Tartu, Estonia
4
Formycon Investigative Site
Batumi, Georgia